GSP INSTRUMENT AND GSP NEONATAL HTSH KIT— 510(k) K090846

Substantially Equivalent

Perkinelmer, Inc.

FDA 510(k) clearance K090846 for GSP INSTRUMENT AND GSP NEONATAL HTSH KIT, Substantially Equivalent on 2009-09-03. Applicant: Perkinelmer, Inc..

Clearance details

Applicant: Perkinelmer, Inc.
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 2009-03-30
Decision date: 2009-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JLW

product code JLW

Malfunction: 885
Total: 885

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.